p-Tert-Butylphenol - UNEP Chemicals

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OECD SIDS P-TERT-BUTYLPHENOL 116 S-9: Rat liver, induced with Aroclor 1254 Metabolic activation: With [ ]; Without [ ]; With and Without [X]; No data [ ] Plates/test: 2 Dose: Metabolic activation: With [ ]; Without [ ]; With and Without [X]; No data [ ] Results: Cytotoxicity conc: 80 µg/ml Precipitation conc: Genotoxic effects: + ? - With metabolic activation: [ ] [ ] [X] Without metabolic activation: [ ] [ ] [X] Method: Other GLP: Yes [X] No [ ] ? [ ] Except that the concentration, homogeneity and stability of test material preparations were not determined by analysis and that this specific study may not have been subject to procedure inspection by the Quality Assurance Unit Test substance: purity: unknown Remarks: Reference: Safepharm Laboratories Ltd.: 1992c * 5.6 GENETIC TOXICITY IN VIVO Type: Species/strain: Drosophila melanogaster Sex: Female [ ]; Male [ ]; Male/Female [ ]; No data [X] Route of Administration: Oral feed in the larval stage Exposure period: No data Doses: No data Results: p-t-Butylphenol induced a change of the colour of body and wings of adult flies; nearly 100 % of the flies showed disturbed wing development; p-tbutylphenol did not cause any mutagenic effect in cells of imaginal buds. Effect on mitotic index or P/N ratio: Genotoxic effects: + ? - [ ] [X] [ ] Method: Other: Morphogenetic Test GLP: Yes [ ] No [X] ? [ ] Test substance: purity: unknown Remarks: Due to poor documentation of this (Russian) publication, it is not possible to evaluate the results of this study. Reference: Zavadsky & Khovanova: 1975 5.7 CARCINOGENICITY Species/strain: Fischer 344 rats Sex: Female [ ]; Male [X]; Male/Female [ ]; No data [ ] Route of Administration: Oral (feed) Exposure period: 51 weeks Frequency of treatment: Daily Post exposure observation period: 1 week Dose: 15 g/kg diet (calculated daily dose as 420 g of body weight and 30 g/day of food consumption: 1.07 g/kg b.w.) Control group: Yes [X]; No [ ]; No data [ ]; Concurrent no treatment [X]; Concurrent vehicle [ ]; Historical [ ] UNEP Publications
OECD SIDS P-TERT-BUTYLPHENOL Results: Rats were administered with or without N-Methyl-N’-nitro-Nnitrosoguanidine (MNNG) at 150 mg/kg b.w. by stomach tube and given diet containing p-t-butylphenol or basal diet one week later. [Without MNNG pretreatment] Decrease in the final body weight and increase in relative liver and kidney weights were observed in p-tbutylphenol treated rats. Histological changes observed in the forestomach were hyperplasia (14/15, 0/10 for treated and control), papilloma (1/14, 1/15), carcinoma in situ (0/15, 0/15), and squamous cell carcinoma (0/15, 0/10). No tumors were observed in the other organs examined such as the esophagus and intestines. [With MNNG pretreatment] Decrease in the final body weight and increase in relative liver and kidney weights were observed in p-t-butylphenol treated rats. Grossly, small papillary or polypoid tumours were found in the forestomach of control rats, while very large single or multiple tumor masses occupied the forestomach in treated rats. Histological changes observed in the forestomach were hyperplasia (20/20, 19/19 for treated and control), papilloma (19/20, 13/19), carcinoma in situ (8/20, 11/19), and squamous cell carcinoma (15/20, 5/19). Squamous cell carcinoma in treated group was significant change, compared to control group. Leiomyosarcoma was induced in one treated rat. As histological change of the glandular stomach, adenocarcinoma of fundic region was only observed in one of treated rats. No tumors were observed in the other organs examined such as the esophagus and intestines. Method: Other GLP: Yes [ ] No [X] ? [ ] Test substance: purity: > 95 % Reference: Hirose et al.: 1988 *5.8 TOXICITY TO REPRODUCTION Type: Fertility [ ]; One-generation study [ ]; Two-generation study [ ]; Other [X] Species/strain: Rats/Crj:CD (SD) Sex: Female [ ]; Male [ ]; Male/Female [X]; No data [ ] Route of Administration: Oral (gavage) Exposure period: Male: 44 days Female: from 14 days before mating to day 3 of lactation Frequency of treatment: Post exposure observation period: Premating exposure period: male: 14 days, female: 14 days Duration of the test: Doses: 0 (Vehicle), 20, 60, 200 mg/kg/day Control group: Yes [X]; No [ ]; No data [ ]; 0.5% aqueous methyl cellulose Concurrent no treatment [ ]; Concurrent vehicle [X]; Historical [ ] NOEL Parental: 200 mg/kg/day NOEL F1 Offspring: 200 mg/kg/day NOEL F2 Offspring: Results: There were no treatment related toxic effects on pregnant and lactating females or their offspring. Method: OECD Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test GLP: Yes [X] No [ ] ? [ ] Test substance: purity: 99.9% UNEP Publications 117
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